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Published: 2017-05-10Captured: 2026-02-09Sysmex America IncProduct: Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
FDA issued a Class II enforcement action. Affects Sysmex America Inc. Reason: Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protecti.
- •Classification: Class II
- •Firm: Sysmex America Inc
- •Status: Terminated
- •Distribution: Nationwide, Canada
Reason
Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of ...
Status:Terminated
Distribution:Nationwide, Canada
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